DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: CPAP SYSTEM, CPAP DEVICE, AND CPAP DEVICE PROGRAM FOR REPORTING EXECUTION AND NON-EXECUTION OF THERAPY.
The disclosure is objected to because of the following informalities:
The last sentence of para [0053] should read “surmises a non-therapy period indicating on which day…the respiratory therapy is not performed.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1 (and thus its dependent claims 2-5), where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “surmise” in claim 1 is used by the claim to mean “determine/calculate from provided data,” while the accepted meaning is “conjecture/suppose that something is true without having evidence to confirm it.” The term is indefinite because the specification does not clearly redefine the term. For purposes of examination, as best understood in light of the specification, “surmise” will be interpreted to mean “determine.”
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 6 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu et al. (US 2022/0076822 A1; hereinafter “Liu”).
Regarding claim 6, Liu discloses a continuous positive airway pressure (CPAP) device system (system 7000 comprising respiratory pressure therapy device 4000) (Figs. 1A, 4C and 8A; [e]xamples of RPT devices include a CPAP device, para [0048]) comprising:
a CPAP device (respiratory pressure therapy device 4000) (Figs. 1A and 4C; [e]xamples of RPT devices include a CPAP device, para [0048]); and
a receiver (within computing device 7050, remote external device 4286, local external device 4288, and/or data server 7100) configured to communicate with the CPAP device (Figs. 4C and 8A; paras [0192-201] and [0331-367]),
wherein the CPAP device is configured to:
determine whether a respiratory therapy with the CPAP device has been performed within a predetermined fixed period (a day) (central controller 4230 will record usage data, para [0198]; the central controller 4230 will send the usage data…after a therapy session…has ended…if no usage session has started on a particular day, the controller 4230 may send the usage data…by 1:00 a.m. or other suitable time the following day…[t]his usage data…would indicate that a certain day or time period included a non-usage day, para [0200]),
transmit execution completion information to the receiver in response to determining that the respiratory therapy has been performed within the fixed period, the execution completion information indicating that the respiratory therapy has been performed within the fixed period (the central controller 4230 will send the usage data…after a therapy session…has ended, para [0200]),
transmit non-execution information to the receiver in response to determining that the respiratory therapy has not been performed within the fixed period, the non-execution information indicating that the respiratory therapy has not been performed within the fixed period (if no usage session has started on a particular day, the controller 4230 may send the usage data…by 1:00 a.m. or other suitable time the following day…[t]his usage data…would indicate that a certain day or time period included a non-usage day, para [0200]), and
wherein the receiver is, as best understood, configured to surmise a non-therapy period in which the respiratory therapy has not been performed based on the execution completion information and the non-execution information (data sent [to the external devices] may be raw data [for determination of]…non-usage days, para [0201]; usage data for each session may be determined [by the data server/external device] from the data received from the device 4000, para [0339]; pattern of non-usage days, para [0381]).
Regarding claim 2, Liu discloses the CPAP system according to Claim 1, wherein the CPAP device is further configured to:
store therapy data during the respiratory therapy in response to the respiratory therapy being performed (device 4000…configured to store in the memory 4260 data from each usage session delivered to the user…therapy data for an RPT session comprises the settings of the RPT device 400 and therapy variable data representing one or more variables of the respiratory pressure therapy throughout the RPT session, para [0336]), and
transmit the therapy data to the receiver, the therapy data being transmitted as the execution completion information or in addition to the execution completion information, the therapy data regarding the performed respiratory therapy indicated by the execution completion information (device 4000…configured to transmit data…usage data may comprise…usage time…apnea-hypopnea index (AHI)…average leak flow rate…average mask pressure, paras [0336-340]).
Regarding claim 3, Liu discloses the CPAP system according to Claim 1, wherein the receiver is further configured to report information regarding the surmised non-therapy period to an external device (computing device 7050, remote external device 4286, local external device 4288, and/or data server 7100) different from the CPAP device (Figs. 4C and 8A; paras [0192-201] and [0331-367]).
Regarding claim 6, Liu discloses a continuous positive airway pressure (CPAP) device (respiratory pressure therapy device 4000) (Figs. 1A and 4C; [e]xamples of RPT devices include a CPAP device, para [0048]) configured to:
determine whether a respiratory therapy with the CPAP device has been performed within a predetermined fixed period (a day) (central controller 4230 will record usage data, para [0198]; the central controller 4230 will send the usage data…after a therapy session…has ended…if no usage session has started on a particular day, the controller 4230 may send the usage data…by 1:00 a.m. or other suitable time the following day…[t]his usage data…would indicate that a certain day or time period included a non-usage day, para [0200]),
transmit execution completion information to a receiver (within computing device 7050, remote external device 4286, local external device 4288, and/or within data server 7100) (Figs. 4C and 8A) in response to determining that the respiratory therapy has been performed within the fixed period, the execution completion information indicating that the respiratory therapy has been performed within the fixed period (the central controller 4230 will send the usage data…after a therapy session…has ended, para [0200]),
transmit non-execution information to the receiver in response to determining that the respiratory therapy has not been performed within the fixed period, the non-execution information indicating that the respiratory therapy has not been performed within the fixed period (if no usage session has started on a particular day, the controller 4230 may send the usage data…by 1:00 a.m. or other suitable time the following day…[t]his usage data…would indicate that a certain day or time period included a non-usage day, para [0200]).
Regarding claim 7, Liu discloses a non-transitory computer-readable medium having instructions stored thereon (Figs. 4C and 8A; memory 4260 acts as a non-transitory computer readable storage medium on which is stored computer program instructions, para [0191]) that, when executed by a controller (central controller 4230) of a continuous positive airway pressure (CPAP) device (respiratory pressure therapy device 4000) (Figs. 1A and 4C; [e]xamples of RPT devices include a CPAP device, para [0048]), causes the CPAP device to:
determine whether a respiratory therapy with the CPAP device has been performed within a predetermined fixed period (a day) (central controller 4230 will record usage data, para [0198]; the central controller 4230 will send the usage data…after a therapy session…has ended…if no usage session has started on a particular day, the controller 4230 may send the usage data…by 1:00 a.m. or other suitable time the following day…[t]his usage data…would indicate that a certain day or time period included a non-usage day, para [0200]),
transmit execution completion information to a receiver (within computing device 7050, remote external device 4286, local external device 4288, and/or within data server 7100) (Figs. 4C and 8A) in response to determining that the respiratory therapy has been performed within the fixed period, the execution completion information indicating that the respiratory therapy has been performed within the fixed period (the central controller 4230 will send the usage data…after a therapy session…has ended, para [0200]),
transmit non-execution information to the receiver in response to determining that the respiratory therapy has not been performed within the fixed period, the non-execution information indicating that the respiratory therapy has not been performed within the fixed period (if no usage session has started on a particular day, the controller 4230 may send the usage data…by 1:00 a.m. or other suitable time the following day…[t]his usage data…would indicate that a certain day or time period included a non-usage day, para [0200]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Levings et al. (US 2017/0186122 A1; hereinafter “Levings”).
Regarding claim 4, Liu discloses the CPAP system according to Claim 1, but Liu is silent regarding wherein the receiver, in response to failing to receive both the execution completion information and the non-execution information in a given period, is configured to not determine whether the respiratory therapy has been performed, the given period being a blank period. However, Levings teaches that it was known in the respiratory device compliance/usage monitoring art before the effective filing date of the claimed invention to include wherein the receiver, in response to failing to receive both the execution completion information and the non-execution information in a given period, is configured to not determine whether the respiratory therapy has been performed, the given period being a blank period (Fig. 5; [a]n unfilled [i.e. blank] therapy icon indicates that no data is available for the patient for the corresponding date, para [0081]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Liu to include wherein the receiver, in response to failing to receive both the execution completion information and the non-execution information in a given period, is configured to not determine whether the respiratory therapy has been performed, the given period being a blank period as taught by Levings, in order to provide the predictable result of alerting a user and/or reviewer when no data has been received to enable assessing whether or not usage has occurred for a given time period (Levings para [0081]).
Regarding claim 5, Liu in view of Levings teaches the CPAP system according to Claim 4, wherein Liu further discloses/teaches wherein the CPAP device is configured to, in response to communication with the receiver being interrupted (e.g. the RPT device is turned off, para [0200]), and after the communication with the receiver becomes possible (the RPT device is turned back on, para [0200]), transmit the execution completion information and the non-execution information to the receiver (the RPT device…will not send the usage data 9045 until it is turned back on and will determine the amount non-usage days since the last session identified, para [0200]), and
wherein the receiver is configured to determine whether the respiratory therapy has been performed within the blank period based on the transmitted execution completion information and the non-execution information after the communication with the receiver becomes possible (see above in combination with the modification discussed regarding claim 4, i.e. Liu discloses the receiver/remote device as the location for data processing, such that the receiver is taught to fill in the blank period once the usage information is received as taught by Levings and in view of Liu para [0200], in order to predictably provide an updated record upon reestablished communication).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Additional references regarding automated tracking and reporting of usage/non-usage in CPAP devices: Aloia et al. (US 2012/0024287 A1); Armistead et al. (US 2017/0311879 A1); Casse et al. (US 2020/0090485 A1); D Andzhelo (RU 2635182 C2); Dittmer et al. (WO 2022/246267 A1); Delangre et al. (US 2017/0239432 A1); Kaigler et al. (WO 2012/028999 A1; Fig. 5A); Kimmel et al. (US 2004/0187871 A1); Lapoint et al. (US 2013/0269700 A1); Molony et al. (US 2023/0246780 A1); Semen et al. (US 2014/0032231 A1); Yurko et al. (US 2011/0113857 A1). Reference regarding the tracking of successful request execution: Trull et al. (US 2021/0146080 A1; para [0231])
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHRYN E DITMER whose telephone number is (571)270-5178. The examiner can normally be reached M 7:30a-3:30p, T/Th 8:30a-2:30p, W 11:30a-4:30p, F 1-4p ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at 571-270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHRYN E DITMER/Primary Examiner, Art Unit 3785
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